Introduction to the International Conference on Harmonisation (ICH)

Overview

The course, a Thomson Reuters Cortellis Regulatory Online Learning module, discusses the establishment of the International Conference on Harmonisation (ICH) technical requirements for registration of pharmaceuticals for human use by the EU, Japan, and United States. ICH membership, structure, and milestones are explored. The course describes the process for harmonisation, implementation of guidelines, and achievements reached in the three regions. The course concludes by describing the impact of ICH global harmonisation efforts on non-ICH countries.

Featured Topics

International Conference on Harmonisation (ICH) technical requirements for registration of pharmaceuticals for human use

Process for harmonisation, implementation of guidelines, and achievements

Who Should Attend

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning Objectives

Participants who complete this course should be able to:

Understand the rationale behind the development of the ICH

Describe ICH structure

Differentiate four categories of harmonisation proposals

Outline the steps of the formal ICH procedure

Describe the harmonisation achievements in the areas of drug efficacy, quality, safety

Contact Information

Technical Requirements

Registration Fees

Other Fees

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.